The FDA is considering revoking the authorization of Pfizer’s COVID-19 vaccine for healthy children younger than 5 years old, adding another barrier for parents who want to vaccinate healthy children ahead of the respiratory virus season. Pfizer’s three-dose shot for children between 6 months and 5 years old has long been available under an emergency use authorization (EUA). The FDA is weighing ending that authorization and has requested that the EUA for this age group remain in place for the 2025-2026 season. Pfizer expects the FDA to approve its vaccine for children ages 5 to 11 with the same limitations as Moderna and Novavax. The FDA has not yet applied for full approval of its COVID-19 vaccine for the youngest age group.
The Department of Health and Human Services (HHS) has not commented on potential changes, but states that Moderna is ramping up supplies of its vaccine for the fall and will be able to meet demand if Pfizer’s vaccine is no longer available for the youngest children. Providers who already preordered Pfizer shots for the coming season will likely be able to switch to Moderna. However, since the Moderna vaccine is only licensed for kids at risk of severe infection, pediatricians will have to offer them “off label” for healthy kids with no guarantee it will be covered by insurance.
